Hemostasis valves are currently used on catheters for performing percutaneous transluminal coronary angioplasty (PTCA), as well as angiographic procedures, for example where x-ray contrast fluid is inserted into the coronary artery.
To prevent the leakage of blood out of ends of known dilitation and guidance catheters, a hemostasis valve is provided at the proximal end of each of them, to prevent seepage of blood between the guide wire and the dilitation catheter and also between the two catheters. For example, currently, numerous types of hemostasis valves are known. See for example Stevens, U.S. Pat. No. 4,000,739.
Hemostasis valves may also be employed for the introduction of other catheters into the circulatory system in a leak proof manner. The valve may be carried by any catheter or sheath introducer which communicates with the circulatory system of the body. Another inner catheter may then be placed through the hemostasis valve, which forms a leak proof seal and a port for entry of the second catheter.
There is a need for improvement of the hemostasis valve, so that an individual valve is capable of accommodating a wider range of catheters, probe wires or the like of varying diameter, to provide increased flexibility to the physician in treating the patient. At the same time, leakage of fluids under the conditions of use must be prevented.
In accordance with this invention, a self-sealing, penetrable barrier is provided, typically for use as a hemostasis valve, which exhibits greater tolerance of varying diameter of catheters or other objects penetrating it without leakage or damage to the valve. At the same time the structure is simple, inexpensive, and manufactured with relative ease.